Trial Outcomes & Findings for A Trial to Reduce Pneumonia in Nursing Home Residents (NCT NCT00975780)
NCT ID: NCT00975780
Last Updated: 2014-11-20
Results Overview
The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
834 participants
Primary outcome timeframe
2.5 years
Results posted on
2014-11-20
Participant Flow
Participant milestones
| Measure |
Usual Care
The usual oral care provided at the nursing home
Usual oral care : Usual oral care and feeding positioning
|
Enhanced Oral Care
Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
|
|---|---|---|
|
Allocation
STARTED
|
400
|
434
|
|
Allocation
COMPLETED
|
400
|
434
|
|
Allocation
NOT COMPLETED
|
0
|
0
|
|
Follow Up
STARTED
|
400
|
434
|
|
Follow Up
COMPLETED
|
298
|
277
|
|
Follow Up
NOT COMPLETED
|
102
|
157
|
Reasons for withdrawal
| Measure |
Usual Care
The usual oral care provided at the nursing home
Usual oral care : Usual oral care and feeding positioning
|
Enhanced Oral Care
Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
|
|---|---|---|
|
Follow Up
Death
|
88
|
122
|
|
Follow Up
Facility Withdrawal
|
7
|
23
|
|
Follow Up
Discharged from Facility
|
7
|
12
|
Baseline Characteristics
A Trial to Reduce Pneumonia in Nursing Home Residents
Baseline characteristics by cohort
| Measure |
Enhanced Oral Care
n=434 Participants
Study participants receiving 'Enhanced Oral Care' in the study
|
Usual Oral Care
n=400 Participants
Study participants receiving 'Usual Oral Care' in the study.
|
Total
n=834 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
86.1 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
86.3 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
329 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
636 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsThe number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.
Outcome measures
| Measure |
Enhanced Oral Care
n=434 Participants
Study participants receiving 'Enhanced Oral Care' in the study
|
Usual Oral Care
n=400 Participants
Study participants receiving 'Usual Oral Care' in the study.
|
|---|---|---|
|
Pneumonia
|
119 participants
|
94 participants
|
SECONDARY outcome
Timeframe: 2.5 yearsThe number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.
Outcome measures
| Measure |
Enhanced Oral Care
n=434 Participants
Study participants receiving 'Enhanced Oral Care' in the study
|
Usual Oral Care
n=400 Participants
Study participants receiving 'Usual Oral Care' in the study.
|
|---|---|---|
|
Lower Respiratory Tract Infection Other Than Pneumonia
|
125 participants
|
100 participants
|
Adverse Events
Enhanced Oral Care
Serious events: 204 serious events
Other events: 391 other events
Deaths: 0 deaths
Usual Oral Care
Serious events: 153 serious events
Other events: 371 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Oral Care
n=434 participants at risk
Study participants receiving 'Enhanced Oral Care' in the study
|
Usual Oral Care
n=400 participants at risk
Study participants receiving 'Usual Oral Care' in the study.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.4%
19/434 • Number of events 23 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
3.2%
13/400 • Number of events 19 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Skin and subcutaneous tissue disorders
Skin / Soft Tissue Event
|
0.92%
4/434 • Number of events 4 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.25%
1/400 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Eye disorders
Eye Infection
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.50%
2/400 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Difficulty
|
12.0%
52/434 • Number of events 74 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
9.2%
37/400 • Number of events 51 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Fall
|
3.7%
16/434 • Number of events 19 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.0%
20/400 • Number of events 21 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Renal and urinary disorders
Acute Renal Failure
|
1.4%
6/434 • Number of events 8 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.75%
3/400 • Number of events 4 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.25%
1/400 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Gastrointestinal disorders
Gastrointestinal Disturbance
|
4.6%
20/434 • Number of events 27 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.2%
21/400 • Number of events 26 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Blood and lymphatic system disorders
Abnormal Blood Glucose
|
0.23%
1/434 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.25%
1/400 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Cardiac disorders
Acute Chest Pain/Coronary Syndrome
|
0.46%
2/434 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
2.0%
8/400 • Number of events 8 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Psychiatric disorders
Altered Mental Status
|
7.6%
33/434 • Number of events 38 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.5%
22/400 • Number of events 27 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Blood and lymphatic system disorders
Anemia
|
0.46%
2/434 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.75%
3/400 • Number of events 3 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Vascular disorders
Blood Pressure Alteration
|
0.23%
1/434 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.50%
2/400 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Weight Loss
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.25%
1/400 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.50%
2/400 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Infections and infestations
Fever
|
1.8%
8/434 • Number of events 10 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
1.5%
6/400 • Number of events 6 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Psychiatric disorders
Generalize Malaise
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.25%
1/400 • Number of events 1 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Other
|
8.8%
38/434 • Number of events 41 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.5%
22/400 • Number of events 28 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Unrelated and Unanticipated OTHER
|
0.00%
0/434 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
0.50%
2/400 • Number of events 2 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Death
|
28.8%
125/434 • Number of events 125 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
23.8%
95/400 • Number of events 95 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
Other adverse events
| Measure |
Enhanced Oral Care
n=434 participants at risk
Study participants receiving 'Enhanced Oral Care' in the study
|
Usual Oral Care
n=400 participants at risk
Study participants receiving 'Usual Oral Care' in the study.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
35.9%
156/434 • Number of events 270 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
32.5%
130/400 • Number of events 211 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Skin and subcutaneous tissue disorders
Skin / Soft Tissue Event
|
62.4%
271/434 • Number of events 880 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
54.2%
217/400 • Number of events 669 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Eye disorders
Eye Infection
|
18.7%
81/434 • Number of events 131 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
16.5%
66/400 • Number of events 84 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Difficulty
|
54.8%
238/434 • Number of events 482 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
57.0%
228/400 • Number of events 449 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Fall
|
32.9%
143/434 • Number of events 300 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
34.5%
138/400 • Number of events 277 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Gastrointestinal disorders
Gastrointestinal Disturbance
|
37.1%
161/434 • Number of events 347 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
28.7%
115/400 • Number of events 230 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Psychiatric disorders
Altered Mental Status
|
22.6%
98/434 • Number of events 184 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
16.5%
66/400 • Number of events 129 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
17.5%
76/434 • Number of events 118 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
16.0%
64/400 • Number of events 107 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
36/434 • Number of events 46 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
6.2%
25/400 • Number of events 36 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Oral Cavity Disturbance
|
11.8%
51/434 • Number of events 57 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
13.8%
55/400 • Number of events 72 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Weight Loss
|
8.3%
36/434 • Number of events 46 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.2%
21/400 • Number of events 22 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Headache
|
7.6%
33/434 • Number of events 51 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
6.2%
25/400 • Number of events 36 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
5.3%
23/434 • Number of events 27 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
3.8%
15/400 • Number of events 24 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
Infections and infestations
Fever
|
7.8%
34/434 • Number of events 43 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
5.5%
22/400 • Number of events 26 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
|
General disorders
Generalized Malaise
|
7.1%
31/434 • Number of events 35 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
4.5%
18/400 • Number of events 31 • Adverse events (both Serious and Other) were collected over the 2.5 year study period.
|
Additional Information
Vincent James Quagliarello MD, Professor of Medicine (Infectious Diseases); Clinical Chief, Infectio
Yale University School of Medicine
Phone: (203) 785-7571
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place